In a petition sent to the FDA, Pfizer sharply criticized several of its competitors for attempting to dissuade patients from trying biosimilars.
The FDA has OK’d four biosimilars made by Pfizer and the company hopes to have five more approved within the next few years. But sales for its biosimilars have been sluggish and overall, the biosimilars market in the has been much slower to take off in the U.S. than it has in Europe.
In particular, Pfizer called out Amgen, Roche and Johnson & Johnson for using “scare tactics” and spreading misleading information about the safety of copycat medications.
As one of its examples, Pfizer referenced a video by Amgen that cautioned against the risks of switching to biosimilars and suggested that it might “not be a good idea” if the patient’s original medicine is already working.
“We believe that a major factor contributing to this slow uptake is a lack of market confidence in biosimilars resulting from the efforts of certain reference product sponsors to disseminate false and misleading information that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescribers," Pfizer said in the petition.
Pfizer pointed out that insurance coverage is also one of the issues hampering sales of biologics. But the company is asking the FDA to clarify what kind of communication from biologic drugmakers is acceptable and how companies that make biosimilars can accurately market their products.
Meanwhile, Pfizer is also suing J&J for allegedly making deals with pharmacy benefit managers to block competition for its biosimilar that’s going head-to-head with J&J’s blockbuster drug, Remicade. That case is expected to set an industry precedent for how other lawsuits related to biosimilar competition are decided.